The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

CDDF Multi-Stakeholder Workshop

Enabling Smarter Clinical Trials to optimize patient care

17 November – 18 November 2025, Hybrid Workshop

Recordings

SESSION 1: Clinical trials and real world evidence: what really matters

Session 1 – complete

Enabling Clinical Trials: Taking a proportionate approach – focusing on what really matters – Juan Estevez (AEMPS, ES)

Fireside chat – Hugues Malonne (FAGG-AFMPS, BE)

Turning Data into Decisions: Real-World Evidence in Regulation – Alexandra Pacurariu (EMA, NL)

Session 1 – Panel discussion

SESSION 2: Use of pragmatic elements in clinical trials

Session 2 – complete

Matching trials aims to design decisions: how PRECIS-2 can help, and how PRECIS-3 will be better – Shaun Treweek (University of Aberdeen, UK)

Patient perspective – Gilliosa Spurrier-Bernard (MelanomeFrance, FR)

Designing trials with pragmatic elements to generate high-quality real-world evidence for regulatory decisions – Nafsika Kronidou-Horst (Roche, CH)

Safety data report – ICH E19 – how we streamline – example of pragmatic elements – regulatory component – Peter Mol (University of Groningen, NL)

Session 2 – Panel discussion

SESSION 3: Driving research using health data

Session 3 – complete

EMA article – clinical evidence 2030 – Marianne Lunzer (CTCG, AT)

Unlocking the Power of Real-World Data Across the Full Lifecycle of Cancer Clinical Trials – Ariel Bourla (Johnson & Johnson, U.S)

From Patient Experience to HTA Evidence: The MyLymphoma Model for Real-World Data Generation – Natacha Bolanos (Lymphoma Coalition, ES)

Supporting drug development through new evidence generation approaches – Alison Cave (Medicines and Healthcare products Regulatory Agency, U.K)

Session 3 – Panel discussion

SESSION 4: Wrap-up and panel discussion

Session 4 – complete